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Unannounced Audits In EU Not Obligatory, Commission Confirms

Will notified bodies be let off the hook when it comes to unannounced audits now that it is official they are not mandatory? And what is the role of national courts in notified body liability?

Compliance Europe Regulation

Infusion Pump-Makers Look to Improve Safety Through Interoperability

While infusion pumps are vital to patient care and used in abundance in hospitals, they are also associated with numerous errors. One of the keys to addressing this problem lies in improving the devices’ interoperability with hospital IT systems, and as those changes are starting to materialize, so are opportunities for new players in this space.

Safety Market Intelligence Commercial

Unlocking Legalities: Gorsuch’s Impact May Be Felt On Free Speech, Preemption

Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.

Unlocking Legalities Legal Issues Policy

Compliance 360° Part 3: Building Trust With US FDA – Can It Be Done?

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.

Quality Control Compliance Quality
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New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Regulation Policy Quality Control

More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

Quality Control Compliance Regulation

Warning Letter Roundup & Recap – Feb. 21, 2017

No device-related warning letters were released by US FDA the week of Feb. 21.

Device Warning Letters Regulation

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Challenges To French High-Risk Device Notification Requirements

France has introduced new requirements for medical devices that go beyond EU requirements. Is the EU going to stand by and let this happen? And which products, exactly, will they apply to?

France Medical Device

CMS Nominee Seema Verma Urges Caution On Competitive Bidding Program

Seema Verma, President Trump’s pick to run the US Medicare agency, told the Senate Finance Committee that rural areas should not have to comply with CMS’ medical supplies competitive-bidding program if it is not a good fit. Verma was also questioned on changes she might make to the Affordable Care Act and the Medicare program, but did not offer many specifics.

Policy Reimbursement

Device Week – Feb. 17, 2017

On this week's Medtech Insight podcast: US House Ways and Means Committee sets out plans for the next two years, including a review of all taxes and fees connected to the Affordable Care Act; Allergan and Hologic enter into separate big-money acquisitions in the aesthetics devices arena; a deep-dive look at the osteoporosis diagnostics market.

Regulation Policy

EU Court Ruling Throws Confusion On Need For Notified Body Unannounced Inspections

The European Court of Justice judgment on the TÜV Rheinland notified-body liability case raises more questions than answers. In particular, there is uncertainty over its impact on the need for notified bodies to perform unannounced audits.

Legal Issues Regulation

Quality Control Explore this Topic

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EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues

Q4 Recalls Snapshot: Numbers Dip Slightly But Remain High; Sterility Troubles Bubble To Surface

The number of device recalls fell slightly in the final quarter of 2016. While troubles with software and mislabeling continue to be a thorn in industry's side, problems with sterility popped up as the third most common reason for a product recall.

Recalls Quality Control

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Efferent Labs' Living Biosensor Could Save Pharma, Device Firms Money

A new implantable cell-based monitoring device that measure cellular interactions in vivo could soon reach the research market to help medical device and pharma companies in their preclinical, and later this year clinical, research. After that, the technology's developer, Efferent Labs, will be setting its sights on clinical applications like chemotherapy monitoring in cancer patients.

Diagnostics Companies Commercial

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Device Week – Feb. 17, 2017

On this week's Medtech Insight podcast: US House Ways and Means Committee sets out plans for the next two years, including a review of all taxes and fees connected to the Affordable Care Act; Allergan and Hologic enter into separate big-money acquisitions in the aesthetics devices arena; a deep-dive look at the osteoporosis diagnostics market.

Regulation Policy

Integra Aims To Bolster Neurology Portfolio With J&J Codman Buy

Only a month after buying the tissue regeneration company Derma Sciences, Integra has announced a much larger acquisition for Codman Neurosurgery. The company says the buy would complement its current neurosurgery portfolio and boost its global reach.

Neurology Deals

£9m NHS Savings With HeartFlow 'Virtual FFR' Gets NICE Nod

UK's National Institute for Health and Care Excellence has recommended the HeartFlow FFRct Analysis for stable patients with a suspected myocardial infarction. NICE was won over by the potential £9m savings that the technology can bring to the National Health Services in the next five years.

Cardiology Diagnostic Imaging

Hologic Stitches Medical Aesthetics Into Women's Health

Hologic is acquiring Cynosure for $1.65bn, saying medical aesthetics will complement its existing OB/GYN and women’s health businesses. It is the latest in a series of recent moves intended to accelerate Hologic’s growth.

M & A Deals

Europe's TAVR No. 4 Buys Into Mitral Valve Space

Transcatheter aortic valve replacement specialist Symetis has made its maiden acquisition, buying preclinical-stage mitral valve repair firm Middle Peak Medical.

Cardiology M & A

Allergan Pays $2bn-Plus For Zeltiq, Expanding Aesthetics Business

Zeltiq's CoolSculpting body-contouring system will be the third "pillar" in Allergan's aesthetics business, along with its existing facial aesthetics and plastic and regenerative surgery lines, the company says.

Aesthetics Deals

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'Selective' JDRF Backs Israeli Injectable Blood Glucose Monitor

An Israeli start-up developing an injectable, miniature continuous blood glucose monitoring implant has secured funding from the Juvenile Diabetes Research Foundation (JDRF) to speed up product development. The investment will be used to bring GluSense closer to its first in-human clinical trial.

Diabetic Care Innovation Deals

Latest From Research & Development

Ethicon-Sponsored Trial Shows Bariatric Surgery Improves Diabetics’ Outcomes

The final five-year results from the STAMPEDE trial, said to be the first randomized controlled trial in the bariatric space, show that bariatric surgery plus intensive medical therapy is more effective than intensive medical therapy alone in combating hyperglycemia in obese patients with type 2 diabetes.

Diabetic Care Surgery

Intensix Data Analytics Demo High Accuracy In ICU Sepsis Detection

An analytics platform developed by Israeli big data company Intensix has shown high accuracy for detecting and predicting sepsis in critical care. The positive results were presented at the Healthcare Information and Management Systems Society (HIMSS) healthcare IT conference in Orlando, Florida.

Digital Health StartUps and SMEs

Starts & Stops: Abbott's Inherited Products Add To Spike In Suspensions

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. This edition highlights an apparent trial-suspension spike in the past month, including three studies that were stopped by Abbott evaluating products it inherited from its acquisition of St Jude Medical.

Clinical Trials Research & Development

OUS Approvals Analysis: Medtronic, Abbott, Abionic Lead 2017 Upswing

The 20 non-US medical device approvals in January, including eight in in vitro diagnostics, four in orthopedics, and three in cardiovascular devices. Big medtech players Medtronic and Abbott, accompanied by much smaller Swiss IVD firm Abionic, led the charge and bagged more OUS approvals than most.

Approvals Research & Development

US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance

The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.

Approvals Innovation

Abbott Finally Joins MRI-Compatibility Club In US CRM Market

The firm’s Assurity MRI pacemaker and Tendril MRI pacing lead, acquired in its recent St. Jude Medical deal, gained US FDA approval after some delay. Lack of this designation has been a competitive challenge for the business in the past year.

Cardiology Approvals
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